[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658110":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":40,"studyPopulation":29,"armGroups":41,"interventions":53,"overallOfficials":29,"centralContacts":63,"locations":69,"responsibleParty":85,"collaborators":29,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":29,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":29,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":114,"whyStopped":29,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Karabuk University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Forced Vital Capacity (FVC)","Forced vital capacity (FVC) will be measured by spirometry with the participant in a seated position using a nose clip. At least three technically acceptable maneuvers will be performed, and the best acceptable value will be recorded in liters (L). The change from pre-intervention to immediately post-intervention will be calculated for each intervention condition. The primary analysis will compare the change in FVC between motor imagery-supported thoracic expansion exercises and thoracic expansion exercises alone.","Before intervention and within 5 minutes after intervention in Period 1, and before intervention and within 5 minutes after intervention in Period 2; the two periods are separated by a 14-day washout interval.",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Change in Forced Expiratory Volume in One Second (FEV1)","FEV1 will be measured by spirometry and recorded in liters (L). The change from pre-intervention to immediately post-intervention will be calculated for each intervention condition.",{"measure":18,"description":19,"timeFrame":12},"Change in Forced Expiratory Flow at 25-75% of FVC (FEF25-75)","FEF25-75 will be obtained from spirometric assessment and recorded in liters per second (L\u002Fs). The change from pre-intervention to immediately post-intervention will be calculated for each intervention condition.",{"measure":21,"description":22,"timeFrame":12},"Change in Peak Expiratory Flow (PEF)","Peak expiratory flow will be assessed using a peak flow meter. Three maximal expiratory efforts will be performed, and the highest value will be recorded. The change from pre-intervention to immediately post-intervention will be calculated for each intervention condition.",{"measure":24,"description":25,"timeFrame":12},"Change in Chest Expansion","Chest expansion will be assessed using a measuring tape placed horizontally around the thorax. The difference between chest circumference at maximal inspiration and maximal expiration will be recorded in centimeters (cm). Three measurements will be performed and the mean value will be used. The change from pre-intervention to immediately post-intervention will be calculated for each intervention condition.",{"measure":27,"description":28,"timeFrame":12},"Change in Peripheral Oxygen Saturation (SpO2)","Peripheral oxygen saturation (SpO2) will be assessed non-invasively using pulse oximetry and recorded as a percentage (%). The change from pre-intervention to immediately post-intervention will be calculated for each intervention condition.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"RANDOMIZED","CROSSOVER","This is a randomized, two-sequence, two-period crossover trial. Participants will be randomly assigned in a 1:1 ratio to one of two intervention sequences. Sequence AB will receive thoracic expansion exercises alone in Period 1 and motor imagery-supported thoracic expansion exercises in Period 2. Sequence BA will receive the same interventions in the reverse order. The two intervention periods will be separated by a 14-day washout interval. Each participant will receive both interventions and will serve as his or her own control.","TREATMENT",{"masking":36,"maskingDescription":37,"whoMasked":38},"SINGLE","The outcome assessor will be blinded to the intervention sequence and treatment condition. Intervention sessions will be administered by a physiotherapist who is not involved in outcome assessment. Participants will be instructed not to disclose the intervention received to the blinded assessor.",[39],"OUTCOMES_ASSESSOR","Children with spina bifida may experience impaired trunk muscle control, thoracic deformity, reduced chest wall mobility, and limitations in respiratory function. Thoracic expansion exercises are commonly used in respiratory rehabilitation to facilitate chest wall movement and ventilation. However, evidence regarding specific respiratory rehabilitation strategies for children with spina bifida remains limited.\n\nMotor imagery is a cognitive process in which an individual mentally simulates a movement or bodily action without performing an additional physical movement. Motor imagery has been used in neurorehabilitation to facilitate motor planning, body awareness, and motor learning. Its integration with respiratory exercises may enhance attention to thoracic movement and respiratory control, but this approach has not been adequately investigated in children with spina bifida.\n\nThis study is designed as a randomized, two-sequence, two-period crossover trial investigating the acute effects of motor imagery-supported thoracic expansion exercises on respiratory function in children with spina bifida. Participants will be randomly assigned to one of two intervention sequences. Sequence AB will receive thoracic expansion exercises alone during Period 1 and motor imagery-supported thoracic expansion exercises during Period 2. Sequence BA will receive the interventions in the reverse order. The two intervention periods will be separated by a 14-day washout interval.\n\nEach intervention session will last approximately 15 minutes. Thoracic expansion exercises will target the upper, middle, and lower thoracic regions. During the motor imagery-supported condition, participants will perform the same physical thoracic expansion exercises while receiving standardized guided imagery instructions designed to promote awareness of chest wall expansion during inspiration and relaxation during expiration.\n\nOutcome assessments will be performed before and immediately after each intervention session. Forced vital capacity (FVC) will be designated as the primary outcome. Secondary respiratory outcomes will include forced expiratory volume in one second (FEV1), forced expiratory flow at 25-75% of forced vital capacity (FEF25-75), peak expiratory flow (PEF), chest expansion, and peripheral oxygen saturation (SpO2).\n\nThe principal comparison will evaluate whether the pre-to-post intervention change in FVC differs between motor imagery-supported thoracic expansion exercises and thoracic expansion exercises alone. Secondary analyses will examine corresponding changes in the other respiratory and chest mobility outcomes. The crossover design allows each participant to receive both interventions and serve as his or her own control.",[42,49],{"label":43,"type":44,"description":45,"interventionNames":46},"Sequence AB","EXPERIMENTAL","Participants assigned to Sequence AB will receive thoracic expansion exercises alone during Period 1, followed by a 14-day washout interval. During Period 2, they will receive motor imagery-supported thoracic expansion exercises.",[47,48],"Behavioral: Thoracic Expansion Exercises","Behavioral: Motor Imagery-Supported Thoracic Expansion Exercises",{"label":50,"type":44,"description":51,"interventionNames":52},"Sequence BA","Participants assigned to Sequence BA will receive motor imagery-supported thoracic expansion exercises during Period 1, followed by a 14-day washout interval. During Period 2, they will receive thoracic expansion exercises alone.",[47,48],[54,59],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":29},"BEHAVIORAL","Thoracic Expansion Exercises","Participants will perform approximately 15 minutes of thoracic expansion exercises targeting the upper, middle, and lower thoracic regions. The physiotherapist will facilitate expansion of the targeted chest wall region during inspiration using standardized verbal and manual guidance. When appropriate, mild manual resistance may be applied during inspiration and individually adjusted according to the participant's ability.",[43,50],{"type":55,"name":60,"description":61,"armGroupLabels":62,"otherNames":29},"Motor Imagery-Supported Thoracic Expansion Exercises","Participants will perform the same approximately 15-minute thoracic expansion exercise protocol while receiving standardized guided motor imagery instructions. During inspiration, participants will be instructed to imagine the expansion of the chest as a rising wave, and during expiration to imagine the wave gradually receding. The imagery will be synchronized with thoracic expansion and the level of manual resistance applied by the physiotherapist.",[43,50],[64],{"name":65,"role":66,"phone":67,"phoneExt":29,"email":68},"Ece Acar","CONTACT","05457925035","eceacar@karabuk.edu.tr",[70],{"facility":5,"status":29,"city":71,"state":72,"zip":73,"country":74,"countryCode":29,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Karabük","Karabük Province","78050","Turkey (Türkiye)",{"type":76,"coordinates":77},"Point",[78,79],32.62768,41.20488,{"lat":79,"lon":78},[82],{"name":83,"role":66,"phone":67,"phoneExt":29,"email":84},"Ece Acar, Assist Prof","acarkosanece@gmail.com",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Ece ACAR","Assist Prof","100658110","motor-imagery-supported-thoracic-expansion-in-children-with-spina-bifida-100658110",false,"NCT07846202","Motor Imagery-Supported Thoracic Expansion in Children With Spina Bifida","Acute Effects of Motor Imagery-Supported Thoracic Expansion Exercises on Respiratory Function in Children With Spina Bifida: A Randomized Crossover Trial","Inclusion Criteria:\n\n* Diagnosis of spina bifida.\n* Age between 7 and 18 years.\n* Clinically stable, with no acute respiratory infection or respiratory distress.\n* Ability to maintain a seated position.\n* Sufficient cognitive ability to understand and follow verbal instructions.\n* Written informed consent provided by the parent or legal guardian.\n\nExclusion Criteria:\n\n* Acute respiratory tract infection or pneumonia.\n* Chronic pulmonary disease.\n* Severe scoliosis or severe thoracic deformity.\n* Serious cardiac or metabolic disease.\n* Inability to cooperate with the assessment or exercise procedures.\n* Inability to understand or perform the motor imagery instructions.","ALL","7 Years","18 Years",{"count":100,"type":101},30,"ESTIMATED","INTERVENTIONAL",[104],"NA","This study will investigate whether adding motor imagery to thoracic expansion exercises can improve respiratory function in children with spina bifida. Motor imagery involves mentally imagining a movement or bodily action without physically performing an additional movement.\n\nChildren with spina bifida will participate in two exercise sessions separated by a 14-day washout period. In one session, participants will perform thoracic expansion exercises alone. In the other session, the same thoracic expansion exercises will be combined with guided motor imagery. The order of the two sessions will be randomized.\n\nRespiratory function will be assessed before and immediately after each session. The primary outcome will be the change in forced vital capacity (FVC). Additional outcomes will include forced expiratory volume in one second (FEV1), forced expiratory flow at 25-75% of forced vital capacity (FEF25-75), peak expiratory flow (PEF), chest expansion, and peripheral oxygen saturation (SpO2).\n\nThe study aims to determine whether combining motor imagery with thoracic expansion exercises produces greater immediate improvements in respiratory function than thoracic expansion exercises alone.",[107],"Spina Bifida",[109,56,110,111,112,113],"Motor Imagery","Respiratory Function","Pulmonary Function","Forced Vital Capacity","Pediatric Rehabilitation","NOT_YET_RECRUITING","2026-09-25",{"date":117,"type":118},"2026-09-29","ACTUAL",{"date":120,"type":101},"2026-10-12",{"date":122,"type":101},"2027-02-05",{"name":5,"class":6},1]